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NCT01518478 · ClinicalTrials.gov registry record · Early Phase 1
Atopic Dermatitis Research Network (ADRN) Influenza Vaccine Pilot
A Early Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Early Phase 1
- Development phase
- 40
- Enrollment target
NCT01518478: Completed Early Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01518478 is a Early Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 40 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01518478, a Early Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
A new flu vaccine which is injected into the skin instead of into the muscle has recently been approved by the Food and Drug Administration for vaccination of the general population including patients with atopic dermatitis (AD). This new vaccine has been shown to work as well as the vaccine which is injected into muscle when tested in people without atopic dermatitis. The primary endpoint of the study is to estimate the variance of the log fold change from baseline in HAI antibody titers for non-atopic controls and participants with atopic dermatitis without a history of eczema herpeticum (ADEH-), following administration of a single dose of the seasonal 2011-2012 Fluzone® Intradermal vaccine.
Primary Outcome
The variance of the log fold change from baseline in HAI antibody titers for non-atopic controls and ADEH- participants, following administration per label of a single dose of the seasonal 2011-2012 Fluzone® Intradermal vaccine.
Interventions
- DRUG Fluzone® Intradermal (Sanofi Pasteur Inc.)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2011-11 |
| Est. Completion | 2012-03 |
| Phase | Early Phase 1 |
What the finished NCT01518478 record still lists
NCT01518478 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 1 intervention - of which Fluzone® Intradermal (Sanofi Pasteur Inc.) is the first listed.
NCT01518478 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01518478 about?
NCT01518478 is a clinical study titled "Atopic Dermatitis Research Network (ADRN) Influenza Vaccine Pilot". A new flu vaccine which is injected into the skin instead of into the muscle has recently been approved by the Food and Drug Administration for vaccination of the general population including patients with atopic dermatitis (AD). This new vaccine has been shown to work as well as the vaccine which i...
What is the current status of trial NCT01518478?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 40 participants. The study started on 2011-11. Estimated completion is 2012-03.
What interventions are being tested in trial NCT01518478?
The interventions under investigation include: Fluzone® Intradermal (Sanofi Pasteur Inc.) (DRUG).
Who is sponsoring clinical trial NCT01518478?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01518478's enrollment target sits among peer trials
40 629th of 2000 higher than 1,312 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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